Senior Validation Engineer

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX seeks an experienced validation leader to manage complex pharmaceutical validation projects, lead teams, and help optimize validation processes. You will coordinate with engineering, quality, and regulatory groups to ensure successful execution within scope and budget.

The role requires a bachelor’s degree and 7+ years in validation or related engineering, with strong knowledge of FDA regulations and IQ/OQ/PQ protocols.

Qualifications

• Bachelor’s degree required or equivalent in science/engineering.
• 7+ years of validation, science/technical or engineering background required; pharmaceutical validation experience preferred.
• Experience with FDA regulations and validation protocols (IQ/OQ/PQ) is essential.
• Project management tools experience is a plus.

Responsibilities

• Analyze, plan, and complete complex validation projects.
• Lead validation/qualification activities and coordinate with cross-functional teams.
• Prepare and execute validation protocols per FDA requirements.
• Drive continuous improvement of validation processes and documents.
• Manage training of staff on procedures and equipment use.
• Provide audit support and participate in inspections when required.

Skills

Validation expertise

Regulatory knowledge

Project management

Facilities validation

Education

Bachelor's degree

Job description

JOB DESCRIPTION

Completes advanced validation projects with peer input and guidance from engineering and validation management. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group. May also lead validation contract support and be responsible for tracking validation hours and budget.

• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
• Receives general project direction. Responsible for project progress.
• Prepares, reviews, and executes computerized system validation protocols per local procedures and Food and Drug Administration (FDA) regulations.
• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
• Serve as project coordinator or project manager for validation/qualification aspects of projects.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.
• Work on special projects as they arise
• Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required .
• Lead continuous improvement activities for the validation program and revise, create and approve validation documents and procedures
• Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case.

Position Summary

JOB DESCRIPTION

Completes advanced validation projects with peer input and guidance from engineering and validation management. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group. May also lead validation contract support and be responsible for tracking validation hours and budget.

Essential Duties & Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
• Receives general project direction. Responsible for project progress.
• Prepares, reviews, and executes computerized system validation protocols per local procedures and Food and Drug Administration (FDA) regulations.
• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
• Serve as project coordinator or project manager for validation/qualification aspects of projects.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.
• Work on special projects as they arise
• Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required .
• Lead continuous improvement activities for the validation program and revise, create and approve validation documents and procedures
• Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case.

Knowledge, Skills & Qualifications

• Has an advanced understanding of validation and regulatory requirements
• Can assess what work supports the validation strategy and make insightful recommendations regarding priorities
• Expert in equipment, utilities and facilities domains of validation. Familiar in other areas of domain expertise within the team.
• Experience using project management tools is a plus.

Education And Experience

• Bachelor’s degree from an accredited college or university
• 7+ years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements And Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Work may be performed in a clean room environment
• Must be able to occasionally move and lift objects of up to 25 lbs

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants